For the treatment of patients with gBRCAm,* HER2-negative, high-risk^† early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy

The OlympiA trial demonstrated significant invasive disease-free survival (IDFS) and overall survival (OS) in patients with gBRCAm, HER2-negative, high-risk eBC with LYNPARZA vs placebo¹

Primary (prespecified interim) analysis

Primary endpoint: IDFS¹

42^%

REDUCTION IN RISK OF INVASIVE DISEASE RECURRENCE, NEW CANCERS, OR DEATH VS PLACEBO

Key secondary endpoint: OS¹

32^%

REDUCTION IN RISK OF DEATH VS PLACEBO

See below for IDFS and OS results from 6-year exploratory analysis^‡

*Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.¹

^†For patients who received prior neoadjuvant chemotherapy, high risk was defined as non-pCR in TNBC and as non-pCR with CPS&EG score ≥3 in HR-positive, HER2-negative disease. For patients who received prior adjuvant chemotherapy, high risk was defined as ≥pN1 or pN0 with ≥pT2 in TNBC and as ≥4 positive lymph nodes in HR-positive, HER2-negative disease.¹

^‡Median follow-up time (exploratory analysis): 6.1 years. The analysis at 6 years is based on Kaplan–Meier estimates and is descriptive only; the OlympiA trial was not powered to assess a statistical difference between treatment groups at this time point.

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PRIMARY (prespecified interim) ANALYSIS

Adjuvant LYNPARZA demonstrated a statistically significant improvement in IDFS* vs placebo in gBRCAm, HER2-negative, high-risk early breast cancer^1,2

IDFS event rates at 1, 2, and 3 years are based on Kaplan–Meier estimates and are descriptive only; the OlympiA trial was not powered to assess a statistical difference between treatment groups at these time points.

The threshold for statistical significance was 0.005¹
The number of IDFS events observed was 106 with LYNPARZA (N=921) vs 178 with placebo (N=915)¹
Data from the prespecified interim analysis (86% of the number of events for the planned final analysis) at a median follow-up of 2.5 years^1,2

*IDFS was defined as time to first invasive breast cancer recurrence (loco-regional or distant), second primary cancer, or death from any cause.¹

^†LYNPARZA was administered for up to 12 months or until disease recurrence or unacceptable toxicity.¹

EXPLORATORY (prespecified third) ANALYSIS*

In an exploratory analysis,* ~80% of patients in the LYNPARZA arm and ~70% of patients in the placebo arm were living without an IDFS event at 6 years^3†

The IDFS event rates at 6 years are based on Kaplan–Meier estimates and are descriptive only; the OlympiA trial was not powered to assess a statistical difference between treatment groups at this time point.

The number of IDFS events observed was 178 (19%) in the LYNPARZA arm and 258 (28%) in the placebo arm; HR=0.65 (95% CI: 0.53–0.78)³
Median IDFS follow-up time (exploratory analysis): 6.1 years³

*Efficacy and safety were assessed with follow-up at 10 years from First Patient In; DCO3: June 2024.³

^†Invasive disease-free survival was defined as the time to first invasive breast cancer recurrence (loco-regional or distant), second primary cancer, or death from any cause.¹

^‡LYNPARZA was administered for up to 12 months or until disease recurrence or unacceptable toxicity.¹

PRIMARY (prespecified second interim) ANALYSIS: SIGNIFICANTLY IMPROVED OS VS PLACEBO

LYNPARZA is the ONLY targeted adjuvant therapy to achieve OS benefit vs placebo specifically in patients with gBRCAm, HER2-negative, high-risk eBC^1,4-9

OS rates at 1, 2, 3, and 4 years are based on Kaplan–Meier estimates and are descriptive only; the OlympiA trial was not powered to assess a statistical difference between treatment groups at these time points.

OS was controlled for Type 1 error within a hierarchical statistical analysis in OlympiA¹⁰
The threshold for statistical significance was 0.015¹
The number of deaths was 75 with LYNPARZA (N=921) vs 109 with placebo (N=915)¹
Data from the prespecified second interim analysis of OS (at ~330 IDFS events) at a median follow-up of 3.5 years^1,7

Adjuvant treatment with LYNPARZA may give your eligible patients the opportunity to live longer¹

*LYNPARZA was administered for up to 12 months or until disease recurrence or unacceptable toxicity.¹

EXPLORATORY (prespecified third) ANALYSIS*

In an exploratory analysis,* ~88% of patients in the LYNPARZA arm and ~83% of patients in the placebo arm were alive at 6 years³

OS event rates at 6 years are based on Kaplan–Meier estimates and are descriptive only; the OlympiA trial was not powered to assess a statistical difference between treatment groups at this time point.

The number of deaths in the LYNPARZA arm was 107 (11.6%) and 143 in the placebo arm (15.6%); HR=0.72 (95% CI: 0.56–0.93)³
Median OS follow-up time (exploratory analysis): 6.1 years³

*Efficacy and safety were assessed with follow-up at 10 years from First Patient In; DCO3: June 2024.³

^†LYNPARZA was administered for up to 12 months or until disease recurrence or unacceptable toxicity.¹

OlympiA Study Design

OlympiA was designed to evaluate LYNPARZA as adjuvant therapy in certain patients with gBRCAm,* HER2-negative, high-risk early breast cancer¹

OlympiA was a phase 3, randomized, double-blind, placebo-controlled, international clinical trial^1,2

The CPS&EG scoring system estimates relapse probability on the basis of pre-treatment clinical and post-treatment pathologic stage (CPS), estrogen receptor (ER) status, and histologic grade.^1,2

*Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.¹

^†At least 6 cycles of neoadjuvant or adjuvant chemotherapy containing anthracyclines, taxanes, or both agents. Platinum-based chemotherapy was allowed.¹

^‡Radiation therapy was given when appropriate.^2,10

^§OS and DDFS were controlled for Type 1 error within a hierarchical statistical analysis in OlympiA.²

Explore related content:

LYNPARZA eBC Data Brochure

Download a resource for complete summaries of efficacy and safety data from the OlympiA trial, a clinical trial for gBRCAm, HER2-negative early BC, including exploratory 6-year follow-up data.

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Dosing and Administration Considerations

LYNPARZA dosing can be modified to help manage adverse reactions.

Review the dosing information and dose modification data from the OlympiA trial.

View LYNPARZA dosing for BC

BC=breast cancer; BID=twice daily; BRCAm=BRCA-mutated; CI=confidence interval; CPS&EG=pre-treatment clinical and post-treatment pathologic stage (CPS), estrogen receptor (ER) status, and histologic grade; DCO3=data cutoff 3; DDFS=distant disease-free survival; eBC=early breast cancer; gBRCA=germline BRCA; gBRCAm=germline BRCA-mutated; HER2=human epidermal growth factor receptor 2; HR=hazard ratio or hormone receptor; IDFS=invasive disease-free survival; OS=overall survival; pCR=pathologic complete response; TNBC=triple-negative breast cancer.

References: 1. LYNPARZA^® (olaparib) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2025. 2. Tutt ANJ, Garber JE, Kaufman B, et al; OlympiA Clinical Trial Steering Committee and Investigators. Adjuvant olaparib for patients with BRCA1- or BRCA2-mutated breast cancer. N Engl J Med. 2021;384(25):2394-2405. 3. Garber J. Pre-specified analyses of IDFS, DDFS and OS 10 years from First Patient In (FPI) in the OlympiA trial of adjuvant olaparib in germline BRCA1/2 mutation-associated breast cancer. Presented at: SABCS 2024; December 11, 2024; San Antonio, TX. 4. Rubraca^® (rucaparib) [prescribing information]. Vienna, Austria: zr pharma& GmbH; 2025. 5. Talzenna^® (talazoparib) [prescribing information]. New York, NY: Pfizer Inc.; 2025. 6. Zejula^® (niraparib) [prescribing information]. Durham, NC: GlaxoSmithKline; 2025. 7. Geyer CE Jr, Garber JE, Gelber RD, et al; OlympiA Clinical Trial Steering Committee and Investigators. Overall survival in the OlympiA phase III trial of adjuvant olaparib in patients with germline pathogenic variants in BRCA1/2 and high-risk, early breast cancer. Ann Oncol. 2022;33(12):1250-1268. 8. Keytruda^® (pembrolizumab) [prescribing information]. Rahway, NJ: Merck & Co., Inc.; 2025. 9. Verzenio^® (abemaciclib) [prescribing information]. Indianapolis, IN: Eli Lilly and Company; 2025. 10. Tutt ANJ, Garber JE, Kaufman B, et al; OlympiA Clinical Trial Steering Committee and Investigators. Adjuvant olaparib for patients with BRCA1- or BRCA2-mutated breast cancer. Clinical Study Protocol. N Engl J Med. 2021;384(25):2394-2405.

The OlympiA trial demonstrated significant invasive disease-free survival (IDFS) and overall survival (OS) in patients with gBRCAm, HER2-negative, high-risk eBC with LYNPARZA vs placebo1

Adjuvant LYNPARZA demonstrated a statistically significant improvement in IDFS* vs placebo in gBRCAm, HER2-negative, high-risk early breast cancer1,2

In an exploratory analysis,* ~80% of patients in the LYNPARZA arm and ~70% of patients in the placebo arm were living without an IDFS event at 6 years3†

LYNPARZA is the ONLY targeted adjuvant therapy to achieve OS benefit vs placebo specifically in patients with gBRCAm, HER2-negative, high-risk eBC1,4-9

In an exploratory analysis,* ~88% of patients in the LYNPARZA arm and ~83% of patients in the placebo arm were alive at 6 years3

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